Medication Guide App

← See all AZO brands

AZO by i-Health, Inc.

Dosage form: tablet
Ingredients: Phenazopyridine Hydrochloride 95mg
Labeler: i-Health, Inc.
NDC Code: 49973-301

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

AZO Urinary Pain Relief

Drug Facts

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 95 mg

Purpose

Urinary analgesic

Use Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.

Warnings  Please read insert for important precautions.

Ask a doctor before use if you have´╗┐

  • kidney disease
  • allergies to foods, preservatives or dyes
  • had a hypersensitive reaction to Phenazopyridine Hydrochloride.

Caution: Do not use this product if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.

When using this product

  • stomach upset may occur, taking this product with or after meals may reduce stomach upset.
  • your urine will become reddish-orange in color.  This is not harmful, but care should be taken to avoid staining clothing or other items.

Stop use and ask doctor if

  • your symptoms last for more than 2 days
  • you suspect you are having an adverse reaction to the medication.

If pregnant or breastfeeding, ask a professional before use.

Keep out of reach of children.  In case of an overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 12 years or older: Take 2 tablets 3 times daily with or after meals as needed for up to two days.  Take with a full glass of water. Do not use for more than 2 days (12 tablets) without consulting a doctor.
  • Children under 12: Do not use without consulting a doctor.

Other Information

  • This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests
  • This product may stain soft contact lenses and other items if handled after touching tablets
  • Store at room temperature (59-86 F) in a dry place and protect from light
  • Tamper evident: tablets sealed in blisters.  Do not use if blister foil or seal is open or damaged.

Inactive ingredientsmicrocrystalline cellulose, pregelatinized corn starch, hypromellose, povidine, croscarmellose sodium, polyethylene glycol, carnauba wax and vegetable magnesium stearate.  May also contain corn starch.

Distributed by i-Health, Inc.

55 Sebethe Drive, Cromwell, CT 06416

Made in India.

Most Trusted Brand based on Nielsen data through 3/23/2013.

For questions, concerns, or to report an adverse event, call (800) 722-3476

www.azoproducts.com

Fast Relief for Urinary Pain

AZO

Urinary Pain Relief

VALUE SIZE

  • RELIEVES PAIN, BURNING & URGENCY
  • TARGETS THE SOURCE OF PAIN

MOST TRUSTED #1 BRAND

30 Tablets
95 mg Phenazopyridine Hydrochloride





AZO 
urinary pain relief tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49973-301
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Phenazopyridine Hydrochloride (Phenazopyridine ) Phenazopyridine Hydrochloride95 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
HYPROMELLOSES 
POVIDONE 
CROSCARMELLOSE SODIUM 
POLYETHYLENE GLYCOLS 
CARNAUBA WAX 
MAGNESIUM STEARATE 
Product Characteristics
Colorbrown (Maroon) Scoreno score
ShapeROUND (Tablet) Size7mm
FlavorImprint CodeW
Contains    
Packaging
#Item CodePackage Description
1NDC:49973-301-3115 BLISTER PACK (BLISTER PACK) in 1 BOX
12 TABLET (TABLET) in 1 BLISTER PACK
2NDC:49973-301-3015 CELLO PACK (CELLO PACK) in 1 BOX
22 TABLET (TABLET) in 1 CELLO PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/24/2012
Labeler - i-Health, Inc. (061427694)
Establishment
NameAddressID/FEIOperations
Amneal Pharmaceuticals, Inc.968119730manufacture(49973-301)

Revised: 02/2014
 
i-Health, Inc.

← See all AZO brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web3)